Efficacy of Prophylactic Fluconazole Therapy in Preterm and Very Low Birth Weight Neonates in Preventing Invasive Fungal Infection.

NCT05848492 | Completed Phase 3 FDA Drug

• 1 other identifier: FluconazolePreterm1
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Invasive fungal infection is detecting candida species in blood, cerebrospinal fluid, or urine. Clinical signs of invasive candidiasis may include lethargy, temperature instability, feeding intolerance, apnea, hypotension, respiratory distress, abdominal distension, and thrombocytopenia. Fungal infection has been associated with an increased risk of retinopathy of prematurity and chronic lung disease. Preterm and low birth weight infants have an immature immune system that predisposes them to infections with bacteria, viruses, and fungi. These infants usually require prolonged admission in the neonatal unit and there is often a need for the administration of broad-spectrum antibiotics which predisposes them to colonization with fungi that may invade to cause systemic disease8. Other risk factors for the development of invasive fungal infection include endotracheal intubation, abdominal surgery, the presence of a central venous catheter, administration of H2 antagonists, and steroids. Infection with Candida species is the third most common cause of bloodstream infection in premature infants. Mortality in preterm infants due to invasive candidiasis is around 20% and can be as high as 50% in infants weighing \<1500g at birth. Invasive candidiasis is the second most common infectious cause of death in extremely preterm infants. The present study was conducted to determine the incidence of invasive candidiasis among preterm and very low birth weight infants in our neonatal unit and to evaluate the efficacy of prophylactic fluconazole in preventing invasive fungal infection. Based on the results of the present study institutional guidelines may be designed in our neonatal unit relating to antifungal prophylaxis in preterm and very low birth weight infants.

Conditions

Invasive Candidiases

Outcome Measures

Primary Outcomes (1)

• Invasive candidiases

  Positive blood, cerebrospinal fluid, or urine culture for candida species will be regarded as invasive candidiasis.

  2 weeks

Study Arms (2)

Prophylactic Fluconazole

EXPERIMENTAL

12 mg/Kg loading dose of fluconazole given intravenously followed by 6 mg/Kg every 48 hours till 14 days of life, and then 6 mg/kg/day thereafter, for a total duration of 6 weeks (42 days).

Drug: Fluconazole

placebo group

PLACEBO COMPARATOR

Normal Saline 2cc given intravenously

Drug: Saline

Interventions

Fluconazole DRUG

Fluconazole will be given for prevention of invasive candidiasis in preterm and very low birthweight babies.

Prophylactic Fluconazole

Saline DRUG

0.9% Saline 2cc intravenous will be given to preterm babies in placebo group.

placebo group

Eligibility Criteria

• Age: 1 Hour - 3 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Preterm babies born less than 34 weeks of gestation
• very low birth weight babies (weighing \< 1500 g at birth)
• Babies \<72 hours of age

You may not qualify if:

• Babies \>72 hours of life
• Syndromic babies
• Babies with suspected metabolic disorders

Sponsors & Collaborators

• Services Institute of Medical Sciences, Pakistan: lead

Study Sites (1)

Services Hospital Lahore

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Candidiasis, Invasive

Interventions

Fluconazole; Sodium Chloride

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• M Tauseef Omer, MBBS FCPS Pediatrics

  Services Hospital, Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-graduate resident

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 8, 2023
• Study Start: May 1, 2021
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: May 8, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)